Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Cerebrovascular Disorders Clinical Trial

Official title:

Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266848
• Other study ID #: R41DA043974
• Secondary ID: R41DA043974
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: July 22, 2020

Study information

• Verified date: August 2021
• Source: Theranano LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.

Description:

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 22, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 to 80;
• Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.

Exclusion Criteria:

• Known allergy to ferumoxytol or any intravenous iron preparation;
• Iron saturation above the upper limit of normal;
• Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
• Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
• Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.

Related Conditions & MeSH terms

• Cerebrovascular Disorders

Intervention

Diagnostic Test:
• Quantitative Magnetic Resonance Imaging
Radiological diagnosis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Theranano LLC	Massachusetts General Hospital, National Institute on Drug Abuse (NIDA), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular Angiography	Obtain angiograms of the cerebral vasculature from the MRI intensity data	0-4 hours after ferumoxytol infusion
Secondary	Quantitative cerebral blood volume atlas	Create cerebral blood volume atlas from the quantitative MRI intensity data	0-4 hours after ferumoxytol infusion